BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24407497 · Received February 20, 2026

    Report

    Report Number
    2955842-2026-05292
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    December 4, 2025
    Report Date
    February 20, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE DAMAGED CONDUCTOR WIRE INSULATION AT THE YAW PULLEY. THERE WAS FRAGMENTATION OF THE INSULATION, AND THE INTERNAL CONDUCTOR WIRES WERE EXPOSED. ALTHOUGH THE CONDUCTOR WIRE INSULATION WAS DAMAGED, THE INTERNAL WIRE WAS NOT FRAYED OR FULLY BROKEN. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. FURTHER INSPECTION FOUND NO ABNORMALLY SHARP OR DAMAGED COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE CABLE BREAKING. THE COMPLAINT REGARDING THERE WAS BLACK WIRE ON ONE SIDE AND DOES NOT RUN IN THE GROOVE WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF DAMAGED CONDUCTOR WIRE INSULATION IS ATTRIBUTED TO DAMAGE FROM MECHANICAL IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS DETECTED IN STERILE PROCESSING AFTER WASHING. NO FURTHER INFORMATION WAS PROVIDED. INTUITIVE SURGICAL, INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: STERILE TECHNOLOGY DISCOVERED THAT THE BLACK WIRE ON ONE SIDE, DOES NOT RUN IN ITS GROOVE, LOOKS STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469040 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K10250717 0204 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.